The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage Tox Drug Screen, Catalog #94000.
| Device ID | K012745 |
| 510k Number | K012745 |
| Device Name: | TRIAGE TOX DRUG SCREEN, CATALOG #94000 |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Contact | Jeffrey R Dahlen |
| Correspondent | Jeffrey R Dahlen BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | MLK |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-16 |
| Decision Date | 2002-01-10 |
| Summary: | summary |